ISO 13485 QMS — Design Plus | ISO 13485 & FDA QMSR
DESIGN PLUS is a quality management system for medical device research and development organizations that do not manufacture, including specification developers. Its focus is design, development and related post-commercialization activities.
Why A.P. Lyon documentation
Written by Aaron Lyon, former Senior Director of Regulatory Affairs, from 30+ years in medical device design and manufacturing
Current to FDA QMSR (effective February 2, 2026) and ISO 13485:2016
Preview before you buy: the gallery shows the actual content-list pages for this package
What customers say
“I have purchased several of your products and I have always been happy with the quality of your work. Thanks for providing a great product.” — A.P. Lyon customer
“We aligned the system to our organization and devices. A P Lyon's procedures were very handy and easy to implement in a couple of months.” — Bal G.
Experience behind the documentation
A.P. Lyon’s quality-system procedure portfolio is in use by organizations in over 45 countries and has been reviewed during FDA, notified-body, and other third-party audits. Each buyer must adapt, approve, and implement the documents for its own activities.
What is included
Quality Management System Manual
45 procedures and related forms, as detailed in the content list
Editable Microsoft Word and Excel content
Digital download
Selected topics described in the package documentation include:
Quality-system documentation and management responsibilities
Design controls, risk management and design analysis
Product specifications, labeling and shelf life
Verification, validation and biocompatibility
Clinical evaluation and investigation
Software development and clinical evaluation
Human factors, customer requirements and failure investigation
Putting the documentation to work
The package provides a starting point for introducing procedures, training personnel and organizing quality-system activities. Using existing documentation allows your team to focus on implementation and the needs of your business.
Adapt responsibilities, workflows and forms to your organization, products and markets. Review the content against your activities, identify additional documentation needs, approve the procedures and train the people who will use them.
Can it be used with an electronic QMS?
Yes. The manual, procedures and forms are editable Microsoft Word and Excel files, so you can import them into any eQMS that manages Office documents or run them as a paper-based system. A typical approach is to load the documents into the system’s document control, route them through its review and approval workflow, and either rebuild the forms as electronic forms or attach them as documents.
Before release, change wet-signature blocks and paper-record wording to match how your system applies electronic signatures and keeps records, and align each procedure’s approval steps with the system’s workflow. Validating the eQMS software for its intended use is your responsibility under ISO 13485:2016 clause 4.1.6 and, for U.S. devices, FDA’s QMSR (21 CFR Part 820), including 21 CFR Part 11 where it applies. The Software Validation Procedure is included in this package and can support that work. The package supplies documentation; it does not configure or validate your software.
For a step-by-step walkthrough, read Using A.P. Lyon Procedures in an eQMS: Import, Adapt and Validate.
Implementation support
A.P. Lyon offers assistance with installation and post-installation quality-system audits. Contact us to discuss the support your organization requires. Implementation timing depends on your organization, the customization needed and the resources available.
For organizations that also manufacture devices, see the 73-procedure MANUFACTURING PLUS system. Use each content list to confirm scope.
Choosing the right package
Review the package scope against your responsibilities before purchase. Procedure counts describe procedures with related forms, not the total number of files.
For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.
Compare Quality System Packages or contact A.P. Lyon about this package.
FDA QMSR & ISO 13485 Resource Center
Practical guide
Read How to Choose a Medical Device Quality Management System for workflow guidance, a checklist and common mistakes.
Upgrade credit: already bought individual procedures from this family? What you paid for them in the last 60 days is credited toward this package. Contact us before you order and we will apply the credit.
License: Single site covers one organization at one site. Consultant, at three times the single-site price, lets a consultant adapt the documents and pass them on to their clients for use in the clients' own systems. See the license terms.
